Statistical SME - Quality Systems - Solothurn, Switzerland

Statistical SME - Quality Systems - Solothurn, Switzerland

Experience:
- Minimum of 7 years experience in statistic preferred in metal industry.
- Compliance experience in the medical device.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.
- Proficient in the use of spread sheet software (Access/Excel etc.)

Degree in Engineering, Chemistry Bsc
§ Experience Medical Device, FDA - must
§ Product Knowledge of cleanliness
§ Knowledge of Zone Concept (clean room etc)

Subject Matter Expert (Acceptance Activities/Statistic):
Role -

- With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
- Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
- Make recommendations to achieve compliance where shortfalls are found.
- Provide Audit reports as directed.
- Develop the new Standard for Inspection Planning on statistic on the EU and eventual the Golden Standard sites.
- Well know statistics (Master-Level).
- Be willing and able to travel domestically to other Legacy Synthes EU sites as required.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Fluently German/English spoken and written
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.).
- Generate URS for new software and tools.
- Good communication skill
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Team player
- Be able to manage effectively multiple priorities and tasks.